advanced practicenursing in multiple...

Supported by an educational grant from Teva Neuroscience.

Kathleen Costello, MS, ANP-BC, MSCNNurse Practitioner/Research AssociateThe Johns Hopkins MS CenterBaltimore, Maryland

June Halper, MSN, APN-C, FAAN, MSCNExecutive DirectorConsortium of Multiple Sclerosis CentersInternational Organization of Multiple Sclerosis NursesHackensack, New JerseyAdvanced Practice NurseMS Center, University of Medicine and Dentistry of New JerseyNewark, New Jersey

Advanced Practice Nursing in Multiple SclerosisAdvanced Skills, Advancing Responsibilities

3RD EDITION

This publication contains reports of medical practices and investigations aspresented at professional scientific meetings. This publication may includediscussion of investigational uses of drugs, devices, and techniques thathave not been recognized as safe and efficacious by the Food and DrugAdministration and investigational uses of drugs, devices, and techniquesthat have been approved for other uses. The opinions expressed in thesematerials are those of the editors and are not attributable to the publisheror educational grant provider. In weighing the benefits of treatment againstthe risks, healthcare professionals should be guided by clinical judgment.Dosages, indications, and methods for the use of drugs, devices, andtechniques referred to herein reflect data that may have been presentedat professional scientific meetings in abstract, oral, or poster format and theclinical experience and discretion of the presenting investigators and/orauthors. Consult complete prescribing information (drugs) and instructionsfor use (devices) before administering any of the agents discussed herein.

Some of the research cited in these materials may have been funded bythe educational grant provider.

Supported by an educational grant from Teva Neuroscience.

Copyright © 2010 by

All rights reserved. None of the contents of this publication may bereproduced in any form without the prior written consent of thepublisher.

Expert Medical Education

EDITORS

Kathleen Costello, MS, ANP-BC, MSCNNurse Practitioner/Research AssociateThe Johns Hopkins MS CenterBaltimore, Maryland

June Halper, MSN, APN-C, FAAN, MSCNExecutive DirectorConsortium of Multiple Sclerosis CentersInternational Organization of Multiple Sclerosis NursesHackensack, New JerseyAdvanced Practice NurseMS Center, University of Medicine and Dentistry of New Jersey

Newark, New Jersey

DISCLOSURES

Ms. Costello has the following relationships to disclose: She has been or is a consultant to Biogen Idec, EMD Serono, and Teva Neuroscience. She has participated in speakers’ bureaus and on advisory boards for Biogen Idec, EMD Serono, and Teva Neuroscience.

Ms. Halper has the following relationships to disclose: She has participated in speakers’ bureaus for Teva Neuroscience and is or has been a consultant to Acorda Therapeutics, Bayer Healthcare Pharmaceuticals, Questcor Pharmaceuticals, Novartis Pharmaceuticals, and Teva Neuroscience.

Table of Contents

Foreword 2

Introduction 3

Overview of Multiple Sclerosis 4

Nursing Care in Multiple Sclerosis 10

Domains of Practice in Multiple Sclerosis Care 14

The APN in Treatment Decisions and 20Symptom Management

Primary-Care Needs in Multiple Sclerosis 23

Measuring Outcomes 26

Conclusion 30

References 31

Acknowledgement 36

1

Advanced Practice Nursing in Multiple SclerosisAdvanced Skills, Advancing Responsibilities

Advanced Practice Nursing in Multiple Sclerosis

2

Foreword

For nearly 2 decades, basic and clinical research have provided greater insight into thepathophysiology of multiple sclerosis (MS) and the impact of early intervention with disease-

modifying therapies. Long-term data regarding most of these therapies indicate that relapsecontrol and delay in disability progression can continue for years with consistent use. Still, forsome patients, the effect of disease-modifying therapy is suboptimal—or, for patients withprogressive forms of MS, ineffective. In these cases, the disease course results in many symptomsand functional disability. The unpredictability of this illness requires lifelong management thatutilizes a multidisciplinary team approach.

The current healthcare environment, with its focus on best practices, evidence-based practice, patient outcomes, and cost-effective care, is suited to the expertise and leadership skillsof advanced practice nurses (APNs). APNs can provide specialized skills and knowledge that arean asset in this milieu and are essential in helping patients manage a chronic illness such as MS.The multiple sclerosis advanced practice nurse (MS APN) has emerged as a nursing leader whoaccepts accountability and responsibility for evidence-based practice and best patient outcomes.As such, the MS APN is best equipped to recognize, understand, practice, and interpret theseconcepts for the broader community of MS professionals and caregivers. To ensure that MSAPNs can continue to provide high-quality, consistent care and add to the body of nursingknowledge, their roles must be well defined, described, and validated through nursing research.

With that goal in mind, the International Organization of Multiple Sclerosis Nurses (IOMSN)convened an Advanced Practice Nurse Advisory Consensus Meeting to define the MS APN’sroles and domains and the practice competencies related to MS care, primary-care needs, andpatient outcomes. This monograph, the third in a series focusing on MS nursing, builds on earlierworks and summarizes the roles, domains, and competencies of the MS APN.

The first monograph described key issues in promoting adherence; detecting, assessing, and maximizing cognitive function; and empowering patients to optimize their quality of life. Thesecond monograph addressed the evolving role of nurses in this field, describing a philosophy andframework, domains and competencies, best practices in disease management and treatment, andopportunities for research. In this monograph, advanced practice nursing in MS is presented as aninternationally recognized branch of nursing that is now specialized and certified. This monograph,now in its third edition, expands on this structure and explores the domains and practices ofAPNs, both in general and specifically in relation to MS.

This monograph is divided into 6 sections: (1) Overview of Multiple Sclerosis, (2) NursingCare in Multiple Sclerosis, (3) Domains of Practice in Multiple Sclerosis Care, (4) The APN inTreatment Decisions and Symptom Management, (5) Primary-Care Needs in Multiple Sclerosis,and (6) Measuring Outcomes.

This monograph presents an expert consensus on APN role definition and clarification thatwill help to validate and perpetuate the role of the APN in MS care throughout the world and,ultimately, benefit those people who are affected by MS.

Kathleen Costello, MS, ANP-BC, MSCN June Halper, MSN, APN-C, FAAN, MSCN

Advanced Skills, Advancing Responsibilities

3

Introduction

An ever-increasing body of medical, nursing, and scientific knowledge has changed the face ofhealthcare, demanding advanced training, expanded skills, and specialized certification, along

with expanded responsibility and accountability. Because of the way these changes impact thecare of patients with multiple sclerosis (MS), advanced practice nurses (APNs) who focus on MScare met at Niagara-on-the-Lake, Ontario, Canada, in September 2002 with 2 goals: (1) to iden-tify and validate the multidimensional nature of the care they provide for patients with MS and(2) to build upon the domains of basic MS nursing recently promulgated by the InternationalOrganization of Multiple Sclerosis Nurses (IOMSN).

A monograph capturing the results of discussions at that meeting was published in 2003. It focused on 3 key areas:

1) defining the domains and roles of the APN in MS care,

2) identifying the importance of the primary-care needs of patients and determining the roleof the APN in addressing those needs, and

3) measuring the effectiveness of the outcomes of APN care.

Underscoring the advanced training, expertise, and responsibilities of APNs, the monographexplored the ways in which APNs complement the contributions of other nursing specialties andMS healthcare team members. A second edition was published in 2005.

This third edition of the monograph builds on the framework of that initial work and incorpo-rates new findings, actions regarding drug safety, and relevant data published in the literature orreported at scientific sessions since then. It also emphasizes the unique problems related toMS—a lifelong disease that requires a multidisciplinary approach to its overall management. It focuses on issues such as the long-term safety and efficacy of immunomodulators, adherenceto therapy to enhance outcomes, and the crucial role of the APN in these challenges to thehealthcare system.

This edition contains additional material not included in the original, such as new informationon clinical trials involving MS therapies and the APN’s role in treatment decisions and symptommanagement.

As with the previous editions, this monograph is dedicated to our patients and their families,for whom we strive to make things better. It is our hope that one day we will better control orcure MS.


4

Overview of Multiple Sclerosis

DEFINITION AND DIAGNOSIS

Multiple sclerosis (MS) affects an estimated 300,000 to400,000 people in the United States and approximately55,000 to 75,000 in Canada.1,2,3 MS is typically diagnosed in early adulthood (most commonly between the ages of 20 and 50) and has a variable course, with about half ofpatients experiencing significant difficulty with ambulationwithin 15 years after disease onset.4

The course of MS varies widely, but may be classified as relapsing-remitting, secondary-progressive, progressive-relapsing, and primary-progressive.5 Most individuals(approximately 80%) begin with a relapsing-remitting courseof MS (RRMS), characterized by episodes of neurologicalsymptoms separated by periods of time with stability ofsymptoms. Common early symptoms are sensory distur-bances, unilateral optic neuritis, double vision, limb-weakness,clumsiness, and bladder and bowel problems; fatigue is alsocommon.4 Cognitive impairment, depression, emotional lability, progressive quadriparesis, tremors, spasticity, andother symptoms of central nervous system dysfunction may develop and become very disabling.4

The diagnosis of MS is based on established clinical andlaboratory criteria.4 The McDonald criteria for diagnosis,originally published in 2001 and revised in 2005, haveattempted to simplify the diagnostic process of MS and tointegrate magnetic resonance imaging (MRI) into the diagno-sis.6,7 The outcomes of the diagnostic process should yieldpossible MS, definite MS, or an exclusion of MS.* Diagnosisrequires 2 attacks, lasting for at least 24 hours and occurringat least 1 month apart, and clinical evidence of 2 or morelesions. Fewer than 2 attacks and/or clinical evidence offewer than 2 lesions require additional evidence of dissemi-nated time and space demonstrated by MRI.7 Cerebrospinalfluid analysis and evoked potential studies may still be incor-porated to provide paraclinical evidence of the disease,although their use today is less frequent than in the past.Patients with a single attack and clinical evidence of onelesion are classified as having a clinically isolated syndrome(CIS).7 By these criteria, MS remains a diagnosis of exclusion.

Differential diagnosis of MS is complex, and consensus guide-lines have been developed to help clinicians systematicallyexclude alternative diagnoses.8

EVOLUTION OF MS CARE PATTERNS

MS care patterns have evolved significantly in recentdecades. In the 1970s and 1980s, the care pattern wasfocused primarily on palliative care and alleviation of symp-toms. However, in the mid 1990s, disease managementoptions and the scope of useful interventions were greatlyexpanded with the development of the immunomodulatorytherapies, along with refinements in diagnostic and monitor-ing technologies.

Today, healthcare professionals have a more comprehen-sive perspective and a more proactive approach towardtreating patients with MS. This approach encompasses every-thing from improving earlier diagnostic efforts to maximizingoverall wellness. At the foundation of all MS treatment is theformalized appreciation of the fact that patients and theirsignificant others are active partners in the care process.

According to the Consortium of Multiple Sclerosis Centers’ Recommendations for Care, because MS is a life-long disease for which there is currently no cure, the health-care team treating patients with MS should seek to providea comprehensive approach to disease management, whichtakes into consideration the medical, social, vocational, emo-tional, and educational needs of the patient and his or herfamily.9 The goal of this comprehensive, integrated approachis to empower patients and their families to maximize independent functioning and quality of life and to preparethem for the adaptations that will come with changes inphysical and cognitive functioning. The reach of this inte-grated care extends beyond the walls of the healthcareoffice(s) and into the patient’s centers of living (eg, homeand work environments) for the duration of the patient’s life.

EVOLUTION OF MS TREATMENT AND EXPECTATIONS

Current goals of MS treatment have expanded beyond management of neurological symptoms to include reducingrelapse rates, slowing disease progression, and preventingresulting disability.10 These expanded goals depend onheightened expectations for medications, which must besafe, effective, and well tolerated over the long term. A brief

* The McDonald criteria were developed to replace previous MS diagnostic criteria established by Poser et al (Ann Neurol.1983;13:227-231), which yields 5 possible results: clinically definite MS, laboratory supported definite MS, clinically probableMS, laboratory supported probable MS, and no MS.


5

review of symptomatic management of MS begins on page 20.

CorticosteroidsCorticosteroids are the accepted standard of care in thetreatment of acute MS relapses, as they may acceleraterecovery from relapse symptoms.4,10,11 The long-term use of corticosteroids, in intermittent pulse therapy or otherforms, has shown uncertain benefit for reducing relapses andresultant disability.10,11 Given the risks associated with long-term corticosteroid use, such as cataracts and osteoporosis,the use of corticosteroids is generally recommended onlyfor short courses during acute episodes.

Disease-Modifying TherapiesThe disease-modifying therapies (DMTs) approved by theFood and Drug Administration (FDA) in the 1990s funda-mentally changed the philosophy of MS care from a para-digm of palliation to a paradigm of relapse reduction anddelay in long-term disability.12,13 In contrast to cortico -steroids, the immunologic activities of the DMTs diminishnew central nervous system (CNS) inflammatory activity,reduce the number of relapses, and, depending on the agent,demonstrate a positive effect on disability progression.Although DMTs do not constitute cures, they hold significantpromise for altering the natural history of MS. In conjunctionwith ongoing care and support by healthcare professionals,these treatments offer patients options that help sustainhope and facilitate an acceptable quality of life.

The DMTs currently approved for use in the UnitedStates and Canada to treat RRMS include the immunomod-ulators glatiramer acetate (Copaxone®) and the interferonbeta (IFN β) agents: intramuscular (IM) IFN β-1a (Avonex®),subcutaneous (SC) IFN β-1a (Rebif®), and IFN β-1b(Betaseron®, Extavia® [Extavia is not available in Canada]),and natalizumab (Tysabri®).14-19 Glatiramer acetate, IFN β-1b, and IM IFN β-1a are also indicated for use in CIS patients. (In Canada, IFN β-1b is also approved to treatsecondary-progressive MS [SPMS].20 Canadian labeling forSC IFN β-1a carries an indication to reduce relapse rate and disease activity on MRI, but not disease progression, inpatients with relapsing SPMS.) In the United States, natalizumab can only be prescribed under the TOUCH™mandatory registration program, described below.19

The immunosuppressant mitoxantrone (Novantrone®) isapproved to treat SPMS, progressive-relapsing MS, or wors-ening RRMS, and is sometimes used in combination withmethylprednisolone.21

The interferons, glatiramer acetate, natalizumab, andmitoxantrone achieve their therapeutic effects through differ-ent mechanisms of action and consequently produce differ-

ent side effects. Most of these side effects are mild to moder-ate, usually subsiding within the first few months after treat-ment initiation. However, some side effects can be seriousand require monitoring or extra caution. For example, treat-ment with mitoxantrone requires monitoring for signs of cardiotoxicity,21 while treatment with the interferons requiresperiodic blood tests to detect blood count or liver abnormal-ities and observation for signs of depression or suicidalideation.15-18 Natalizumab therapy increases the risk of devel-oping progressive multifocal leukoencephalopathy (PML), and due to this risk, natalizumab can only be administered to patients registered in the United States with the TOUCHPrescribing Program.19 In Canada, patients are advised to register with the Canadian Tysabri Care Program™. 20 Dosingand administration information, side effects, label warnings,and nursing implications for each of these agents are summa-rized in Table 1.

MS CLINICAL TRIALS

As APNs caring for MS patients, it is important to under-stand the importance of pivotal clinical trial data and subse-quent long-term follow-up studies involving MS therapies.Randomized clinical trials have laid the foundation for cur-rent MS drug therapy. First, they established that each of the currently available DMTs has favorable effects on MSrelapses and may prolong the time to sustained disabilityprogression in a significant proportion of patients.21-27

Most DMTs also reduce disease activity as measured byMRI.22,27-30 Other randomized studies have demonstratedthat initiating interferon or glatiramer acetate therapy in CISpatients at the first sign of clinical demyelination can signifi-cantly delay the development of clinically definite MS.31-36

Longer-term data from these pivotal trials and other trialssupport the sustained safety and clinical benefits of theimmunomodulators, with added evidence coming from MRI scans.30, 37-43 In the most recent and ongoing phase in the evolution of evidence-based drug therapy for MS,head-to-head clinical trials have been conducted to comparedisease-modifying agents directly, and other trials have beenconducted to explore their use in new combinations.

DMT Clinical Trial DataPatients enrolled in the phase III pivotal trials of the DMTs—the IFN β agents and glatiramer acetate—had establishedRRMS for an average of 4 to 8 years, high relapse rates, andmild or no disability at entry. Relapse rates in these trialsshowed a consistent reduction of approximately 30%.45

Investigators have continued to elucidate the effects of theseagents on measures of progressive disability, various MRI

TABLE 1. Disease-Modifying Therapies14-19, 21

Interferons Glatiramer acetate Interferon �-1a Interferon �-1a Interferon �-1a Natalizumab Mitoxantrone(Copaxone®) (Avonex®) (Rebif®) (Betaseron®, Extavia®) (Tysabri®) (Novantrone®)

Type

Indication (US)

Route

Administration

Dosage (US)

Common side effects/ warnings

Nursing implications


6

Polypeptide mixture

RRMS and CIS

SC injection

Daily

20 mg

• Injection-site reactions• Vasodilatation• Rash• Dyspnea• Chest pain• Immediate post-injection

reaction

• Monitor for injection-sitereactions

• Ensure that drug isgiven SC only

• Educate regardingpotential side effects,problem solving, andavailable resources

Recombinant protein

Relapsing forms of MSand CISIM injection

Weekly

30 µg

• Mild flu-like symptoms• Muscle aches• Decreased peripheral

blood counts• Headaches• Anaphylaxis• Depression or suicide

ideation• Hepatic injury or failure

• Help patient establishexpectations of therapy

• Monitor for injection-sitereactions, liver and bloodabnormalities,neutralizing antibodies

• Observe for depression,suicidal ideation


Recombinant protein

Relapsing forms of MS

SC injection

3x/week

44 µg

• Mild flu-like symptoms• Muscle aches• Anemia• Injection-site reactions• Anaphylaxis• Depression or suicide

ideation• Hepatic injury or failure

• Monitor for injection-site reactions, liver andblood abnormalities,neutralizing antibodies



Recombinant protein

Relapsing forms of MS andCISSC injection

Every other day

0.25 mg

• Flu-like symptoms• Injection-site reactions

and necrosis• Anaphylaxis• Depression or suicide

ideation • Menstrual disorders• Mild neutropenia,

anemia, andthrombocytopenia

• Abnormal liver function(blood testing forleucopenia and liver andthyroid function required)

• Monitor for injection-sitereactions, liver and bloodabnormalities,neutralizing antibodies



Recombinant humanizedmonoclonal antibodyRelapsing forms of MS

1-hour IV infusion

Every 4 weeks

300 mg

• Headache • Fatigue• Arthralgia• Urinary tract infection • Hypersensitivity reactions• Liver injury• PML (rare)

• Monitor forhypersensitivity reactions,signs of liver injury, andany signs or symptomsof PML

• Ensure that drug isnever given as anintravenous push orbolus injection.


AntineoplasticanthracenedioneSPMS, PRMS, or abnormallyworsening RRMS5- to 15-minute IVinfusionEvery 3 months

12 mg/m2 (cumulativedose not to exceed 140 mg/m2)• Nausea• Alopecia• Menstrual disorders/

amenorrhea• URI or UTI• Cardiotoxicity, CHF, and

decreases in LVEF• Secondary AML

• Monitor for evidence ofcardiotoxicity, CHF, anddecreases in LVEF;evaluation of LVEF byechocardiogram orMUGA prior to eachcourse of treatment

• Monitor for IV infusion-site reactions and signsof extravasation

• Ensure that drug isnever given SC, IM, or intra-arterially


• Test for blood and liver abnormalitiesbefore each course of treatment

• Pregnancy tests forwomen prior to eachcourse of treatment

outcomes, and long-term safety and efficacy, in both RRMSand CIS. Below is a brief review of selected landmark studiesfor the DMTs.

IFN -1a IM (Avonex®). The intramuscular preparationof IFN β-1a was investigated in a double-blind, placebo-con-trolled, multicenter trial (the MSCRG Study) of 301 patientswith RRMS, whose main endpoint was time to sustained disability progression of at least 1.0 point on the KurtzkeExpanded Disability Status Scale (EDSS).24 After 2 years,

34.9% of placebo-treated patients demonstrated progressivedisability compared to 21.9% of those treated with 30 µgIFN β-1a (P=0.02), a 37% relative reduction in risk.15,24 Inter-feron-treated patients had significantly fewer exacerbations(P=0.03), with an annual relapse rate of 0.61 over 2 years vs 0.90 for placebo. In addition, treated patients had a signifi-cantly lower number and volume of gadolinium (Gd)-enhanced brain lesions on MRI (P=0.02–0.05).24

Subsequently, the Controlled High Risk Subjects Avonex


7

Multiple Sclerosis Prevention Study (CHAMPS) showed thatthe benefits of IFN β-1a IM therapy could be extended toindividuals with an isolated demyelinating event. In this trialof 383 patients, who received IV steroids for their exacerba-tion and were randomized to 30 µg IFN β-1a IM or placebo,DMT treatment significantly delayed the time to develop-ment of a second exacerbation compared to placebo after 3 years (P=0.002), and was associated with reduced numberand volume of brain lesions at 18 months.33 Most recently,10-year data from an open-label extension of CHAMPS(Controlled High Risk Avonex Multiple Sclerosis PreventionStudy in Ongoing Neurologic Surveillance [CHAMPIONS])showed continued benefit from early treatment in reducingdisease progression.46

IFN -1a SC (Rebif ®).The Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in MultipleSclerosis (PRISMS) study compared the effects of IFN β-1aSC at 2 doses (44 mcg and 22 mcg, 3 times per week) withplacebo in 560 patients with RRMS. After 2 years, bothdoses were more effective than placebo in reducing thenumber and frequency of relapses; exacerbations werereduced by 29% and 32% compared to placebo at the lower and higher doses, respectively. Treated patients alsodemonstrated delayed progression of disability, and a largerproportion were relapse-free with treatment compared toplacebo.22 Analysis of MRI results showed that treatmentreduced the burden of disease from brain lesions comparedto placebo, an effect confirmed in long-term follow-up.37

In the PRISMS-4 extension study, placebo patients werecrossed over to IFN β-1a SC while others continued blindedtreatment with their originally assigned dose for another 2 years.30 The benefits of active treatment were maintainedin the latter group, while crossover patients had fewerrelapses and less disease activity and MRI lesion burden thanthey exhibited during the placebo-controlled phase. Patientsreceiving IFN β-1a from the beginning of the original trialhad consistently better efficacy outcomes at 4 years than thecrossover group. Long-term follow-up extended to 8 yearsin the PRISMS cohort (including 68.2% of the original studypatients, 72% of whom were still receiving IFN β-1a), andcontinued to demonstrate clinical and MRI benefit fromearly vs delayed treatment.38

The Early Treatment of MS (ETOMS) trial demonstratedbenefits of early IFN β-1a SC treatment in patients with afirst neurologic event suggestive of MS and abnormal MRIfindings.36 A total of 308 such patients were randomized to receive either weekly IFN β-1a SC (22 µg) or placebo.After 2 years, 34% percent of treated patients and 45% ofthose on placebo had progressed to clinically definite MS, a relative reduction of 24% (P=0.047). Relapse rate was 33%vs 43% on placebo (P=0.045), and MRI activity was signifi-

cantly lower with active treatment. IFN -1b (Betaseron®). In the pivotal trial for this

DMT, 372 patients with RRMS were randomized either toplacebo, or to 1 of 2 doses of IFN β-1b (1.6 MIU or 8 MIU),for 2 years.23 Compared to placebo, IFN β-1b reduced theannual relapse rate by about 30%. After 2 years, exacerba-tion rates were significantly reduced for both lower- andhigher-dose treatment groups (1.17 and 0.84 respectively)compared with 1.27 for placebo (P=0.0001), with a dosage change among groups. A decrease in mean lesion area wasobserved in the high-dose group.23 Treatment benefits weresustained for up to 5 years, with a one-third reduction inrelapse rate in the higher-dose treatment group comparedto placebo for each year.39 In a report from this pivotal trial’s16-year long-term follow-up study, early and sustained expo-sure to IFN β-1b treatment was strongly associated withreduced risk of negative outcomes including an EDSS scoreof 6.0 or higher, wheelchair use, or progression to SPMS.40

Early treatment with IFN β-1b was supported by theBetaferon/Betaseron in newly emerging multiple sclerosis for initial treatment (BENEFIT) trial, which randomized 468patients within 60 days of an isolated demyelinating event toeither 0.25 mg or placebo every other day.31 After 2 years,treated patients had a lower rate of conversion to definiteMS. Among patients who entered an open-label follow-upphase, those who received early treatment had a 37% lowerrisk of progression to MS (P=0.003) at 5 years comparedwith those initially on placebo.32

Glatiramer acetate (Copaxone®). In the pivotal trial of glatiramer acetate, 251 patients with RRMS were randomized to either 20 mg a day of glatiramer acetate orplacebo for 2 years.25 Compared to the placebo group,patients on treatment showed a 29% reduction in relapserate, the study’s primary endpoint. The final 2-year relapserate was 1.19 for treated patients and 1.68 for placebo(P=0.007).

Of the DMTs used to treat MS, glatiramer acetate has themost serially collected data in the clinical trial setting and thelongest duration of continuous follow-up, reported at 6, 8,and 10 years.41-44 At 6 years, during an open-label crossoverphase of the trial described above, patients treated with thedrug from randomization showed a steady decline in relapsefrequency: a mean of 1.5 per year at entry and a mean of0.42 over all 6 years, a 72% reduction (P=0.0001).41 Thosewho began with placebo and later switched to active treat-ment (after a mean of 30 months) showed a lesser declinein relapse frequency and also fared worse in degree of dis-ability compared to those receiving ongoing therapy.41,42 At8 years of observation, these results remained consistent,suggesting the importance of early and continued therapy.43

After a decade, 62% of patients receiving ongoing therapy


8

with glatiramer acetate had stable or improved EDSS scores,compared to 58% of patients treated for an average of 7years and 28% of patients who withdrew from the studyand returned for evaluation.44 The open-label extension trialhas continued and is now at 15 years.

The European/Canadian MRI Study was a multinationalrandomized trial that used MRI to document the effect ofglatiramer acetate on disease activity in 239 patients withRRMS.28 After 9 months, treatment significantly reduced MRImeasures of MS disease activity and burden: The mediancumulative number of T1 Gd-enhancing lesions was 11 intreated patients and 17 in the placebo group (P=0.003).14,28

The relapse rate was also significantly reduced by 33% fortreated patients (P=0.012).28 In a 9-month open-labelextension, investigators found a 54% reduction in the meannumber of enhanced lesions for those who switched fromplacebo to glatiramer acetate, with an additional 24.6%reduction for patients treated from the study’s outset.47

For treatment in CIS, the PreCISe Study, which random-ized 481 such patients to either glatiramer acetate or placebofor up to 3 years, showed that the risk of developing clinicallydefinite MS was reduced by 45% in the treated group vsplacebo, and the time to development of definite MS was386 days longer.35 The proportion of patients who experi-enced a second attack at 3 years was 43% in the placebogroup vs 25% in the glatiramer acetate group (P<0.001).

Natalizumab (Tysabri®). Natalizumab has a short but eventful history in the treatment of MS due to both itsdemonstrated efficacy and concerns about its safety. Striking efficacy results on clinical and MRI endpoints were observed in2 trials: the 2-year natalizumab safety and efficacy in RRMS(AFFIRM) study and the safety and efficacy of natalizumab incombination with IFN β-1a in patients with RRMS (SENTINEL)study.27,48 Data from AFFIRM revealed a 68% reduction inannual relapse rate compared to placebo and significantlyreduced numbers of brain lesions on MRI.27 Other positiveresults were reported from SENTINEL, such as a reduction in annual relapse rate of about 54% at years 1 and 2 withnatalizumab/IFN β therapy compared to interferon alone.48

After being voluntarily withdrawn from the market by itsmanufacturer in 2005 due to 3 cases of PML and receivingFDA approval to return to the market in 2006, there havebeen >20 cases of PML worldwide in MS patients takingnatalizumab.49 Research to identify risk factors of PML mayhelp clinicians better identify patients who would benefitfrom natalizumab treatment. The risk of PML seems toincrease with the number of natalizumab infusions,50 and as the long-term safety of the drug continues to be moni-tored, it is recommended that the drug be administered topatients who have had an inadequate response to, or areunable to tolerate, other therapies.19

Mitoxantrone (Novantrone®).Two-year clinical trialdata on mitoxantrone in patients with worsening RRMS, progressive-relapsing MS, or SPMS showed significantly fewertreated relapses in patients treated with mitoxantrone vsthose on placebo (24.08 vs 76.77, respectively; P=0.0002).26

There were also fewer new Gd-enhancing lesions shown onMRI among patients taking mitoxantrone than among thoseon placebo (0% vs 16%, respectively; P=0.02).

Several trials have suggested that a brief induction ofmitoxantrone followed by immunomodulatory therapy may be of benefit. In a trial of 40 patients with RRMS who received either 3 monthly infusions of 12 mg/m2

mitoxantrone followed by 12 months of 20 mg glatirameracetate or glatiramer acetate alone, a greater reduction inthe number of Gd-enhancing lesions was observed inpatients receiving induction therapy than those only on glatiramer acetate (89% reduction at months 6 and 9[P=0.0001]; 70% reduction at months 12 and 15[P=0.0147]).51 Mean relapse rates were also lower in theinduction group (0.16) than the glatiramer acetate group(0.32). In another study that also showed the benefit ofmitoxantrone induction,52 103 patients with very activeRRMS were observed for 3 years. One group received 20 mg monthly mitoxantrone plus 1 g monthly methyl -prednisolone for 6 months, followed by a 3-month thera-peutic window, after which they received IFN β-1b for 27 months. A second group received IFN β-1b monthly for3 years with 1 g methylprednisolone for the first 6 months.Among those receiving the mitoxantrone induction, morepatients were relapse free and fewer had fixed disability thanamong patients who did not receive mitoxantrone.

With regard to long-term safety of mitoxantrone, the registry to evaluate Novantrone effects in worsening MS(RENEW) study evaluated the safety and tolerability of 172 patients receiving mitoxantrone for 5 years. Ten patientsexperienced congestive heart failure and 3 patients devel-oped leukemia.53 Researchers determined that the resultscorroborate with previously reported adverse events expe-rienced with mitoxantrone. Smaller studies, however, suggestthat the rates of congestive heart failure and treatment-related leukemia in mitoxantrone-treated patients may behigher than previously reported.54,55

Head-to-Head Trial DataIn the past decade, results from several head-to-head trials have offered clinicians direct comparative data forimmunomodulatory agents for MS. The randomized,prospective, multicenter INCOMIN (Independent Compari-son of Interferon) trial compared treatment with alternate-day IFN β-1b to once-weekly IFN β-1a IM in 188 patientswith RRMS. Over 2 years, IFN β-1b appeared significantly

more effective, with 51% of patients in that treatment group remaining relapse-free compared with 36% of thoseon IFN β-1a IM (P=0.03).56 Development of active lesionson MRI was also strongly reduced by IFN β-1b compared to IFN β-1a.57

The EVIDENCE trial in patients with RRMS showed subcutaneous IFN β-1a (44 µg tiw) to be significantly moreeffective than a lower-dose, lower frequency regimen ofintramuscular IFN β-1a (30 µg qw) in reducing relapses andMRI activity, at 24 and 48 weeks of treatment. This advantagewas sustained for at least 16 months.58

More recently, 3 randomized clinical trials have comparedthe efficacy and safety of glatiramer acetate with high-doseIFN β therapy in RRMS, all indicating comparable efficacy inrelapse reduction and other primary endpoints.59 In theREbif vs Glatiramer Acetate in Relapsing MS Disease(REGARD) trial, 764 patients were randomized to eitherIFN β-1a SC or glatiramer acetate for 96 weeks, with no significant difference observed in time to first relapse, thestudy’s primary outcome.60 For the secondary outcomes, a subset of 460 patients given serial MRI scans showed nosignificant difference in the number and change in volume ofactive T2 lesions or in the change in volume of Gd-enhanc-ing lesions, brain-lesion volume or activity; although those onIFN β-1a treatment had fewer Gd-enhancing lesions thanthose on glatiramer acetate (0.24 vs 0.41, respectively;P=0.0002). Tertiary outcomes of the annual relapse raterevealed no significant difference.

In the open-label, multicenter BEYOND (Betaferon Efficacy Yielding Outcomes of a New Dose) trial—thelargest of the 3 direct-comparison studies—2,244 patientswere randomized to either glatiramer acetate or 1 of 2 doses of IFN β-1b (either the standard 250 µg or 500 µg)for 2 years.61 In all 3 pair-wise comparisons, the primary out-come of relapse risk did not significantly differ ; mean annual-ized relapse rate over 2 years of treatment declined byabout 80% in all 3 arms of the trial, with no significant difference observed among them in EDSS progression orMRI activity. Flu-like symptoms were more common in IFN-treated patients (P<0.0001), while injection-site reac-tions were more common in those given glatiramer acetate(P=0.0005).

The relatively small BECOME (Betaseron vs Copaxone inMultiple Sclerosis with Triple-Dose Gadolinium and 3-TeslaMRI Endpoints) study compared IFN β-1b (250 µg, everyother day) to glatiramer acetate (20 mg daily) in 75 patientswith RRMS.62 The study relied on an optimized MRI proto-col to measure the primary outcome of combined activelesions per scan during 1 year of treatment; the mean numberof lesions declined in both treatment groups (0.63 vs 0.58 inthe IFN β-1b and glatiramer acetate groups, respectively)

but without significant difference between groups (P=0.58).Over the study’s 2-year duration, there were also no signifi-cant differences between the 2 groups in the number ofnew lesions and clinical relapses.

The Modern MS Clinical TrialThe results of the REGARD, BEYOND, and BECOME trialssuggest an efficacy more similar than different on clinical end-points, and, to a less-certain extent, on MRI activity as well.63,64

Until new therapeutic alternatives are available, the selectionof a first-line agent for RRMS may depend more on adverseeffects and adherence issues than on differing efficacy.

It is worth noting that some trials in this second genera-tion of DMT research, or so-called modern MS trials, such as REGARD, have reported markedly lower relapse ratesamong subjects than relapse rates seen in the earlier DMTpivotal trials.65 In REGARD, for example, relapse rates werelower than expected in both groups, raising the possibilitythat populations in later clinical trials have different character-istics, such as a higher proportion of patients at an earlierstage or with lower disease activity. Broader inclusion criteria,earlier diagnosis, and higher awareness of MS among physi-cians and patients might all contribute to this effect. TheREGARD investigators suggested that a trial population withsuch low disease activity might limit the ability to predict clini-cal advantage based on earlier trials.60 To meet the challengeof such low on-study relapse rates, the designers of futureclinical trials may need to modify inclusion criteria, increasetrial sample size, or otherwise increase the power of clinicaltrials to reveal distinctions among therapeutic options.59,60

Emerging TherapiesBeyond today’s DMTs, various novel approaches to MS therapy are under development. These include oral immuno -modulatory agents such as cladribine, fingolimod, laquinimod,and teriflunomide. Phase II and phase III trials of these agentshave, thus far, proven them to be safe and effective in theshort term.66-69 While oral agents to treat MS would offer ahighly sought-after alternative to injectible agents, long-term(≥5 years) safety issues are not yet known and may be ofconcern. Also under investigation are several monoclonalantibodies, including alemtuzumab and rituximab, and experi-mental approaches such as hematopoietic stem-cell trans-plantation.70 As APNs caring for patients with MS, it isimportant to be knowledgeable about treatments understudy, including potential mechanisms of action, outcomemeasurements, risks, and expected time to trial completion.As the race for an oral or otherwise new MS therapy quick-ens, eagerness and excitement should be tempered withaccurate and professional guidance that is in the best inter-est of the patient.


9


10

EMERGENCE OF MS AS A NURSING SPECIALTY

The expanded strategies and approaches to MS treatmenthave had dramatic implications for nurses. The role of thenurse has grown in both depth and breadth to accommo-date the increased need for education and healthcare management in treating MS. The enhanced spectrum of carerequires the abilities of highly skilled nurses who can meetthe needs of patients at any point on the health–illness con-tinuum and in a range of settings, including primary, acute,specialized, and rehabilitative care.The variety of MS diseasecharacteristics mandates multidisciplinary care and special-ized nursing care for optimal outcomes. This provides theMS nurse with many potential opportunities to play pivotalroles in patient care at many different levels of interventionand interaction. Such opportunities arise because of thebroad range of MS signs and symptoms, the unpredictabledisease course, the need for long-term treatment and peri-odic clinical and MRI assessments, the need for consultationand interaction with other health professionals in a variety ofspecialties and disciplines, and the need for ongoing patientsupport.71,72

To fill this growing need, nurses who specialize in MS have begun to attain higher levels of knowledge and moresophisticated skills. In addition, new roles for the MS nursehave been articulated, new domains defined, and new certifi-cation procedures established by the International Organiza-tion of Multiple Sclerosis Nurses (IOMSN) to recognize theattainment of expertise and team leadership skills. Foundedin 1997, the IOMSN currently has about 2,000 members. It has established a specialized branch of nursing, developedstandards of nursing care, supported nursing research, andeducated both professionals and laypeople. Progress in theseareas is ongoing; the ultimate goal of the IOMSN remains to improve the lives of all those persons affected by MSthrough the provision of appropriate healthcare services. An international certification board was established as a sep-arate entity in 2001, and the first certification examinationwas administered in 2002. As of 2005, there are approxi-mately 700 nurses with special certification in MS nursing, up from about 400 nurses in 2002. During the same time,numerous advanced practice nurses (APNs) have becomeincreasingly involved in MS care and research throughoutNorth America.

EVOLUTION OF THE ROLE OF APNS IN NORTH AMERICA

The concept of specialty nursing was introduced in 1900,when an article by Dewitt on the development of special-ized clinical practice within the nursing profession appearedin the first issue of the American Journal of Nursing.73 Dewitt’sarticle appeared at a time when hospitals offered theirnurses apprenticeship-model postgraduate courses in areassuch as anesthesia, tuberculosis, dietetics, and surgery.74 Anurse who had completed such a course or one who hadextensive experience and expertise in a particular clinicalarea was deemed a specialist.

As new discoveries in science and medicine were incor-porated into clinical practice, the need for specializationgrew. In the early 1960s, concerns about providing health-care services for the disadvantaged, along with a push forgreater nurse education, spurred the development of therole of the nurse practitioner (NP).75 By the mid-1970s,more than 500 NP programs existed in the United States.The American Nurses Association published guidelines forNPs in 1974, and a credentialing program was developed in1976. In Canada, the heavy involvement of the governmentin the healthcare system and the federation structure of thegovernment impeded the development of the NP. However,by 1993, NP guidelines were established and post-baccalau-reate programs developed. The first Extended Class Regis-tered Nurses (RNs; equivalent to NPs) were registered bythe Canadian Nurses Association in 1998.

In the 1970s and 1980s, several state nursing practice acts fostered both the continued evolution of the NP roleand the contemporary use of the term advanced practicenursing. As newly defined, the term was meant to encompassNPs and other advanced nursing specialists, such as certified registered nurse anesthetists (CRNAs), certifiednurse-midwives (CNMs), and clinical nurse specialists(CNSs). The state nursing practice acts also served todemonstrate areas of common ground among the variousadvanced practice specialties.74

A growing body of literature attests to the generally positive impact of advanced primary-care nursing roles onpatients, nurses, and clinicians.76 The conceptual basis ofadvanced practice nursing continues to be elucidated and itscore definition refined and clarified—key steps in enhancing

Nursing Care in Multiple Sclerosis


11

its internal cohesion and increasing its legitimacy and recog-nition within and beyond the healthcare professions.77 On aglobal level, APNs are a critical component of cost-effectivehealthcare delivery now and in the future. However, manychallenges remain in the areas of classification and regulation,with inconsistencies regarding roles and titles persistingacross national boundaries.78

ROLE OF THE MS APN

The MS APN plays many roles, including:1) administrator,2) educator,3) collaborator,4) consultant,5) researcher,6) advocate, and7) expert clinician.

Each of these roles is associated with its own set of respon-sibilities, functions, and skills. Qualifications necessary to fulfillthese roles have been identified, along with inherent con-straints that exist.

AdministratorAlthough not all APNs function as administrators, the con-sensus of the original attendees at the 2002 APN AdvisoryConsensus Meeting in Ontario, Canada, (see page 36) wasthat this was potentially an important facet. As an adminis-trator, the MS APN is responsible for staff (including hiring,supervision, and scheduling), budget, policies and procedures,and quality assurance outcomes. The MS APN’s responsibili-ties as an administrator are similar in many important waysto the case management and case-outcomes managementresponsibilities of the clinical nurse specialist (CNS).79 AsSparacino points out, the CNS case manager is involvedwith, and frequently directs, resource management and clinical systems development. In contrast, the CNS case-outcomes manager has even broader responsibilities, includ-ing clinical and financial analysis, outcomes for a particularpatient population, development and revision of organiza-tional systems, quality assurance, research, provider educa-tion, and development and implementation ofinter disciplinary practice improvements.

EducatorThe MS APN is responsible for teaching a variety of audi-ences about MS, including patients and their families, physi-cians and allied health professionals, students, employers,and the community. For the patient and the family in par-

ticular, the MS APN provides information about the following.• Implications of an MS diagnosis• Pathophysiology and natural history of MS• Prognostic indicators (both positive and negative)• Realistic expectations with regard to lifestyle and treat-

ment options• Pharmacologic management of MS

– Disease modification using immunomodulators– Education about current clinical trials and nursing

research in MS care– Symptom and side-effect management

Using their highly specialized knowledge and expertise, MSAPNs can help dispel misconceptions, interpret research andclinical trial data, help patients make informed decisionsabout their care, empower patients to participate as fullpartners, and instill hope in patients and families.

CollaboratorCollaboration is central to the role of any APN and is essen-tial to optimizing outcomes. The MS APN works with a varietyof health professionals, including physicians, rehabilitation specialists, and psychologists, to ensure that patients receiveappropriate care and follow-up. Collaboration with othernurses also leads to increased recognition of nurses as criticalmembers of the healthcare team.79 The MS APN collaborateswith community-based agencies to facilitate access to services,such as transportation, Meals on Wheels, home care, andother available community support. In addition, the MS APNcollaborates with industry to develop tools and strategiesrelated to disease modification and technology, such asintrathecal pumps, assistive devices, and communication aids.

ConsultantThe MS APN makes his or her expert knowledge availableto others via internal or external consulting. Internal consult-ing addresses the needs of patients, staff nurses, and otherhealthcare professionals, whereas external consulting assiststhe nursing profession, specialty organizations, and healthsystems outside the practice setting with approaches andsolutions for specific problems.79 Consulting permits theidentification and solution of a variety of aspects of patientcare,80 including therapy and treatment options, manage-ment of side effects, availability and use of adaptive devicesand equipment, use of unapproved therapies, and referrals asnecessary. For the MS APN, a crucial aspect of consulting isserving as a liaison to industry, employers, insurance compa-nies, and government agencies that deal with disability issuesto clarify MS and its widespread implications.


12

ResearcherAPNs take an active role in clinical practice research, devel-oping practice guidelines, and reviewing outcome and per-formance measures.81 Moreover, the MS APN may functionas principal investigator for a clinical practice research study,coordinate various aspects of the research effort, examinepatients participating in the study, and help evaluate out-comes. Outcomes research may include patient response topharmaceutical and rehabilitation interventions and may alsoinvestigate patient satisfaction, cost of care, or utilization ofservices.

AdvocateThe MS APN serves as an advocate for patients and staff members, and as an agent for change in dealings withhealthcare providers, allied health professionals, the commu-nity, and healthcare systems. Patient advocacy involves negotiating for the patient with respect to work, legal issues,obtaining appropriate treatment, and making informedchoices about treatment. Staff advocacy entails providingemotional and situational support for staff nurses and oth-ers to prevent and resolve conflict in their work environ-ment, reduce stress, and improve clinical judgment in themanagement of patient problems.80 The MS APN acts as acatalyst in terms of monitoring the standard of patient care,guiding staff in the acquisition of clinical skills and knowl-edge, interpreting advanced practice nursing for medicalprofessionals and the community, developing innovativeapproaches to clinical practice, and promoting interdiscipli-nary collaboration.80

Expert ClinicianMany APNs view their most important role—and the heart of advanced practice nursing—as that of the expertclinician.79,82 In this role, APNs in all areas of specializationhave prescriptive authority in all US states and severalprovinces of Canada and are responsible for assessment,diagnosis, treatment, evaluation, and ongoing management of patients. The MS APN demonstrates an in-depth under-standing of the pathophysiology of MS; appropriate interven-tions, particularly DMTs; symptom management; anddiagnostic tests. In addition, the MS APN makes referrals asnecessary, counsels patients, promotes wellness, and servesas the coordinator of individualized patient care.

QualificationsThere are unique characteristics required for the role of theMS APN. These are:• Autonomy, which includes practicing without supervision,

making decisions independently, and managing one’s owntime and workload

• Accountability for the care provided, including quality ofcare, patient satisfaction, efficient use of resources, and clin-ical behavior81

• Authority, as reflected by the 7 roles of the APN and the 4 domains of advanced practice nursing

• Accessibility, which includes being available to patients andeasing or eliminating patient barriers to care, such as needfor transportation, administrative hurdles, reimbursement,language, and culture81

• Leadership, as implied by the APN’s 7 roles and reflectedby the comprehensive care, professional persona, andscholarly inquiry domains of advanced practice nursing

Constraints and BarriersThe following were found to be common constraints or bar-riers to the development of the APN role.79,80,82,83

• Varying education levels upon entry to practice

• The ambiguous role of nursing within the health arena

• Pay scales not commensurate with the degree of responsi-bility, education, or experience

• Lack of reimbursement by insurance companies for theAPN

• Lack of authority and/or autonomy in some settings, under-scoring the need for collaborative practice agreements

• Inadequate support from nursing organizations, educa-tional institutions, and fellow nurses

• Gender-specific preconceptions stemming from nursing’shistory as a female profession

• Paucity of research into the role of APNs and their impacton patients and patient outcomes

• The variety of roles in MS care

Skalia and Hamric suggest several ways to overcome thesebarriers.82 These include drafting mutual agreements withthe scope of practice defined; developing consensus regard-ing scheduling and workload; marshaling organizational sup-port for the APN role; forming interdisciplinary networks forcollaboration, consultation, and referral; and obtaining andmaintaining peer support.

APN PRACTICE PATTERNS IN MS CARE

During the 1960s and 1970s, the terms expanded andextended appeared in the literature to suggest a horizontallystructured movement that encompassed expertise in medi-cine and other disciplines. By comparison, the more contem-porary term advanced suggests a more vertically structuredmovement that encompasses increasing expertise and post-


13

baccalaureate education in nursing itself rather than in otherdisciplines.74

By consensus, the MS APN is a master’s-prepared expertnurse who manages, within the philosophical boundaries ofthe nursing profession, the complex medical problems andrelated issues faced by patients with MS and their familiesacross the disease continuum. This includes promotion ofwellness, restoration of health, prevention of illness, andmanagement of disease, with the goals of instilling hope andempowering patients to participate in their own care aspartners in a therapeutic alliance and not merely as recipi-ents of care.

The evolution of management strategies and treatmentoptions in MS has generated a corresponding evolution inMS APN practice patterns. The MS APN plays a pivotal rolein the multifaceted aspects of establishing, continuing, andsustaining care across the health–illness continuum. Theseareas of care are presented in the monograph for MS nursesentitled Multiple Sclerosis: Best Practices in Nursing Care.72

These aspects of MS care apply to any member of the inter-disciplinary team, including the MS APN:

• Establishing care is the foundational step and includesbuilding a relationship of trust and partnership with thepatient, assessing educational needs and meeting them, anddetermining the support system available to the patient.

• Continuing care builds on this foundation and fosters thepartnership through the provision of information to thepatient on disease and medication management, adher-ence to the regimen, self-care and wellness strategies, andfamily involvement and support.

• Sustaining care involves approaches to maximize thepatient’s well-being through coordination of community,public, and private resources, and through coordination ofcare with appropriate specialists in multiple disciplines.

The advanced MS nursing practice can be found in hospi-tals, neurology offices, MS centers, rehabilitation units, andpatients’ homes. As care patterns evolve, these practice set-tings may expand to primary care settings and into otherspecialty units.

Notes


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D omains are realms of accountability and responsibilityfor the performance of identified tasks. The 4 MS nurs-

ing domains include clinical practice, education, advocacy, and research. These domains serve as the foundations forthe more specialized domains of the APN. Conceptualframeworks and models for advanced practice nursing guide the development of MS advanced practice domains.77

A schematic conceptualization of how these domains inter-relate within the field of MS nursing is presented in Figure 1.

MODELS AND FRAMEWORKS OF ADVANCED PRACTICE NURSINGOf the advanced practice nursing models and frameworksdescribed in the literature, 4 have emerged as relevant toadvanced practice nursing in MS: (1) Benner, (2) Fenton, (3) Brykczynski, and (4) Hixon. Benner’s seminal contributionto nursing was the novice-to-expert model.84 Her practicalmodel continues to guide the development of nurse compe-tency through a clinical judgment process and is drawn onby nurse leaders to further refine and define the advancedpractice nursing domains.

Benner’s Domains of Expert PracticeBecause nursing is a practice discipline, Benner undertook to identify and define clinical knowledge competencies thatnurses could draw on to improve practice. Benner definescompetency as “an interpretively defined area of skilled per-formance identified and described by its intent, functions, andmeaning.”84 She identifies 7 domains of nursing practice thatcan provide direction for APNs (Figure 2).85 She expands ona model of skill acquisition termed the Dreyfus model (Drey-fus S, Dreyfus H. A 5-stage model of the mental activitiesinvolved in directed skill acquisition. Unpublished study; 1980).

Expanding on BennerThe Dreyfus model was utilized by several APNs to enhanceknowledge and skill acquisition. Hixon, in describing the tran-sition of the APN from novice to expert practitioner, devel-oped a model incorporating the Benner domains (Table 2).86

Applying Benner’s expert practice model to advanced prac-tice NP skills acquisition, Brykczynski identified additionaldomains and competencies to be used by NPs in ambulatorycare settings.87 Four competencies are necessary in the man-agement of patient health–illness status: (1) assessing, moni-toring, and coordinating patient care over time; (2) detectingacute or chronic disease while attending to illness; (3) sched-uling follow-up patient visits to monitor care; and (4) selectingand recommending diagnostic and therapeutic interventions.

Brykczynski identified 4 competencies in monitoring and

Advanced PracticeNursing Domains

Consultation

Professional Persona

Scholarly Inquiry

APN-PatientRelationship

Education

Multiple Sclerosis

Nursing Domains

ResearchAdvocacy

Clinical Practice

FIGURE 1. Multiple Sclerosis Nursing Domains

Diagnostic/patient

monitoringfunctions

Administering/monitoringtherapeutic

interventionsand regimens

Monitoring/ensuring

the qualityof health-

care practices

Organizationand work rolecompetencies

Healing roleof the nurse

Teaching/coachingfunction

Effectivemanagement ofrapidly changing

situations

FIGURE 2. Benner’s Domains of Expert Practice

Domains of Practice in Multiple Sclerosis Care

Reprinted from Hamric AB, Spross JA, Hanson CM, eds. Advanced Nursing Practice: An Integrated Approach. Philadelphia, PA: Saunders; 1996:33-51.85

©1996, with permission from Elsevier.


15

ensuring quality health care practices: (1) developing strate-gies for dealing with concerns over consultation, (2) self-monitoring and seeking consultation as necessary, (3) using physician consultation effectively, and (4) giving con-structive feedback to ensure safe practices. Other compe-tencies used by Brykczynski, adapted from Benner, includedbroad domains of organization and work role competencies,teaching/mentoring/coaching, and consulting.87

Advanced practice CNS competencies are also groundedin the Benner expert model. Fenton expanded on the Benner model to develop CNS competencies.88 The addi-tional competencies identified by Fenton, in brief, are:• Recognizing recurrent generic problems resolvable by

policy change• Coping with staff and organizational resistance to change• Grooming staff to see their roles as part of the organization• Providing support for nursing staff• Making the bureaucracy respond to patient/family needs• Providing emotional and informational support for

patients’ families• Providing patient advocacy by sensitizing staff to patient

dilemmas• Interpreting the role of nursing to others

Strong Model of Advanced PracticeThe Strong Model of Advanced Practice was developed in 1994 by APNs and faculty members at Strong MemorialHospital of the Rochester Medical Center in Rochester, New York (Figure 3).89 This model defines and identifies 5 domains of advanced practice and describes the activitiesin each domain. The domains include (1) direct comprehen-sive care, (2) support of systems, (3) education, (4) research,and (5) publication and professional leadership. Each domainincorporates the direct and indirect care activities of theAPN. Unifying the domains and activities of the Strongmodel are the conceptual strands of collaboration, scholar-ship, and empowerment that describe the attributes ofadvanced practice nursing, the approach to care, and theprofessional attitude that defines practice.

Brown ModelIn contrast to the models of advanced practice nursing that primarily address the direct care practice of APNs,Brown proposed a broad, comprehensive conceptual frame-work for advanced practice nursing to guide the develop-ment of curricula, shape role descriptions and practiceagreements, and provide direction for research.90 The frame-work, shown in Figure 4, consolidates and integrates thedefining elements, competencies, characteristics, outcomes,

TABLE 2. Novice-to-Expert Characteristicsof Performance

NOVICE• Has a narrow scope of practice• Develops diagnostic reasoning and clinical decision-

making skills• Needs frequent consultation and validation of clinical skills• Needs and identifies mentor• Establishes credibility• Develops confidence

ADVANCED BEGINNER• Enhances clinical competence in weak areas• Enhances diagnostic reasoning and clinical decision-

making skills• Begins to develop the educator and consultant roles• Incorporates research findings into practice• Sets priorities• Develops a reference group• Builds confidence

COMPETENT• Has an expanded scope of practice• Feels competent in diagnostic reasoning and clinical

decision-making skills• Begins to develop administrator role• Develops organizational skills• Views situations in multifaceted ways• Senses nuances• Relies on maxims to guide practice• Feels efficient and organized• Networks

PROFICIENT• Incorporates direct and indirect role activities into daily

practice• Enhances clinical expertise• Conducts or directs research projects• Is an effective change agent• Uses holistic approach to care• Interprets nuances

EXPERT• Has a global scope of practice• Cohesively integrates direct and indirect roles• Has an intuitive grasp• Has a greater sense of salience• Is a reflective practitioner• Empowers patients, families, and colleagues• Serves as a role model and mentor

Adapted with permission from Hixon ME. Professionaldevelopment: socialization in advanced practice nursing. In: Hickey JV, Ouimette RM, Venegoni SL, eds. Advanced PracticeNursing: Roles and Clinical Applications. 2nd ed. Philadelphia, PA:Lippincott; 2000:46-65.86

and multiple contexts of advanced practice nursing into abroad comprehensive model. Specifically, this model includesa holistic perspective, partnership with patients, use ofexpert clinical reasoning, and diverse approaches to patientmanagement. It comprises the 4 main concepts of environ-ments, role legitimacy, advanced practice nursing, and out-comes, in addition to 17 more specific concepts. Advancedpractice nursing itself is defined by its 5 attributes: focus,domains of activity, orientation, scope, and competencies(Table 3).91

Common Elements of Advanced Practice NursingAdvanced practice care is provided across the spectrum ofhealthcare: acute, chronic, long-term, and rehabilitative services with substantial positive outcomes in terms ofhealth, wellness, and cost of care. A recent study publishedin the Journal of the American Academy of Nurse Practitionersconcluded that employer-sponsored nurse practitioner primary healthcare services afforded enhanced wellness,health promotion, increased access to care, reduced illness,and employee productivity.92 DeVries et al described thebenefit of group medical appointments with a chronic careteam in terms of health outcomes and patient satisfactioncoordinated and directed by an advanced practice nurse.93

Although these and other models and frameworks differin several important ways, they all reflect common elementsshared by APNs.91

• APNs are RNs with a master’s or doctoral degree in aspecialized area of advanced practice nursing

• APNs have had supervised practice during their graduatetraining and ongoing clinical experiences

• APNs are committed to ongoing learning and acquisitionof new knowledge, skills, and competencies

The models and frameworks underscore how APNs differfrom RNs without advanced training who are involved inbasic or standard nursing practice (Table 4).91

DOMAINS OF ADVANCED PRACTICE NURSING IN MS

Important differences exist between APNs in other areas of specialization and APNs specializing in the care of patients with MS (MS APNs). The unpredictability of theprogression of MS and the lack of uniformity of diseasepresentation require a keen ability to assess and managethe care of MS patients and their families. The MS nurse,particularly the certified MS nurse, has knowledge and skillsadequate to establish, continue, and sustain the care ofpatients and families.

MS APNs have a considerable impact on the health andwell-being of patients with MS. The competencies requiredto sustain care are described below through delineation ofthe domains specific to MS APN practice.


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Environments: Society, Healthcare Economy, Local Conditions, Nursing, Advanced Practice Community

Outcomes••••

PatientHealthcareNursingIndividual

Advanced Clinical PracticeProfessional involvementin healthcare discourse

Managing health-care environments

CompetenciesScope ClinicalCare

Advanced Practice Nursing

Role Legitimacy•••

Graduate EducationCertificationLicensure

FIGURE 4. Brown’s Framework on Advanced Practice Nursing

Reprinted from Brown SJ. A framework for advanced practice nursing. J Prof Nurs. 1998;14:157-164.90 ©1998, with permission from Elsevier.

Scholarship Collaboration

Patient

Novice Expert

Education Publication andprofessional

leadership

Directcomprehensive

careSupport ofsystems

Research

Empowerment

FIGURE 3.The Strong Model of Advanced Practice

Reprinted from Mick DJ, Ackerman MH. Advanced practice nursing roledelineation in acute and critical care: application of the Strong Model ofAdvanced Practice. Heart Lung. 2000;29:210-221.89 ©2000, with permis-sion from Elsevier.


17

Domain DefinitionsDomains are realms of accountability and responsibility for the performance of explicit competencies. The domainsidentified and defined in the Benner, Strong, and Brownmodels are antecedents of the 4 domains of MS advancedpractice nursing:

•The nurse–patient partnership

• Comprehensive care throughout the health–illness continuum

• Professional persona• Scholarly inquiry

These 4 domains, unique to advanced practice MS nursing,and their qualities or tasks are normally exclusive andexhaust all areas of practice or scope of practice, attitudes,knowledge, and skills. The major focus of the domains of MS advanced practice nursing centers on how the MS APNinteracts with patients, their families, and others who provide

care. Each domain, along with its qualities, is discussed in further detail below.

The Nurse–Patient PartnershipThe nurse–patient partnership domain describes the depthand breadth of the MS APN relationship to patients. Thisdomain’s qualities include:

• Therapeutic alliance built on mutual trust and respect, withthe patient as partner-participant

• Education and teaching

• Promotion of health and well-being

• Social and family interactions

• Empowerment

• Autonomy

• Expert clinicianship

• Collaboration

• Advocacy

• Flexibility

• Coaching

• Holistic care

Comprehensive Care Throughout the Health–Illness ContinuumGiven the unpredictability of MS and the relapsing-remitting nature of the disease, the domain of comprehen-sive care across the health-illness continuum is of particularrelevance to sustaining the care of patients with MS andtheir families. Within this domain, the biological, psychologi-cal, social, and spiritual needs of patients and their partnersand families must be met holistically. Specifically, this involvesthe following:

• Assessment of the response to chronic illness, emotionalstatus, support networks, environment, culture-specificneeds, vocational issues, financial and insurance resources,transportation needs, lifestyle, activities of daily living,potential for abuse and neglect, and gender-specific issues

TABLE 4. How Does the APN Role DifferFrom the RN Role?

• APNs have an advanced education beyond basic nursingprogram

• APNs engage in complex clinical reasoning and decision-making related to complex patient problems

• APNs possess advanced skills in managing organizations,systems, and environments

• APNs practice with greater autonomy

• APNs exercise a higher degree of independent judgment

• APNs use well-developed communications skills withmultidisciplinary teams and systems across complexhealthcare environments

Adapted with permission from Hickey JV. Advanced practicenursing at the dawn of the 21st century: practice, education,research. In Hickey JV, Ouimette RM, Venegoni SL, eds. AdvancedPractice Nursing: Roles and Clinical Applications. 2nd ed. Philadelphia,PA: Lippincott; 2000:3-8.91

TABLE 3. Elements of Advanced Practice Nursing

Attributes: Focus Domains of Activity Orientation Scope Competencies

Elements: Clinical care • Advanced clinical practice • Holism • Specialization • Core• Managing healthcare • Partnership • Expansion • Role emphasis

environments • Expert clinical reasoning • Autonomy• Professional involvement in • Reliance on research • Accountability

healthcare discourse • Diverse ways of assisting

Reprinted from Brown SJ. A framework for advanced practice nursing. J Prof Nurs. 1998;14:157-164.90 © 1998, with permission from Elsevier.


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• Interventions such as educating patient and family aboutMS, managing crises, counseling, referring to supportgroups, enhancing self-esteem, guiding, and providing hope

• Evaluation and follow-up of treatment, referrals, and adher-ence to therapy and plan of care, as well as knowledge ofcommunity resources, government services, insurance andreimbursement practices, and other issues necessary toimplement biopsychosocial tasks

Other qualities and tasks in this domain are as follows.

• Direct and indirect care, including assessing, monitoring,coordinating, managing the patient’s health status, andreferring to specialists

• Patient–family outcomes, including assessment ofpatient–family response to treatment interventions andmodification of plan of care as necessary

• Promotion of health and well-being

• Innovative practice and problem-solving strategies

• Collaboration with other members of an interdisciplinaryteam and with other services to optimize the patient’shealth status

• Consultation with others and for others

• Education of patient and family with regard to MS diseasecourse, treatment, symptom management, psychologicaland coping skills, and vocational and recreational needs

• Leadership within the team responsible for the patient’s care

• Case management

• Evidence-based practice

• Quality assurance

• Advocating self-care strategies and skills and negotiatingfor the patient with regard to the healthcare system, thehealth policy arena, and access to care

• Health policy and legislation

• Economic accountability

• Teaching patients, families, and colleagues about MS andmodifying teaching for special populations

• Ethical accountability

Professional PersonaThis domain involves the skills and sense of professionalidentity that distinguish advanced practice nursing in MS. The MS APN incorporates the norms, values, and ethical

standards of advanced practice nursing in MS into his or herprofessional behavior and maintains the professional personaby performing the identified tasks in this domain, whichinclude the following.

• Upholding ethical standards of practice and facilitating theprocess of ethical decision making in patient care

• Maintaining autonomy

• Adhering to all aspects of professional accountability

• Serving as an expert in MS for patients, families, colleagues,allied health professionals, and community groups

• Promoting health and well-being

• Suggesting innovative practices and problem-solvingstrategies to answer clinical questions

• Collaborating with other health professionals,departments, and services to optimize patient care,improve strategic planning, and recommend policy changes

• Serving as a consultant to improve patient care andnursing practice

• Educating colleagues, community groups, special interestgroups, and professional groups about MS

• Maintaining competencies in oneself and colleagues

• Providing and sustaining leadership for patients andcolleagues

• Developing, implementing, and evaluating standards ofpractice, policies, and procedures

• Evaluating quality assurance measures

• Serving as an advocate to increase awareness of MS—andthe MS APN—among community and professional groups

• Obtaining and maintaining professional recognition viaspecialty certification and other means

• Participating in efforts to influence health policy andlegislation

• Being flexible to possible changes in MS treatmentparadigms and to changes in healthcare environments andpolicies

• Increasing professional involvement in administration,policy issues, continuing education, MS organizations andconferences, and the larger medical community

• Serving as a mentor, coach, teacher, and/or role model forpatients, colleagues, students, and other medicalprofessionals


19

Scholarly InquiryThe domain of scholarly inquiry provides the MS APN withnumerous opportunities to strengthen the professional per-sona and go beyond the boundaries of patient care whileproviding comprehensive and holistic care and nurturing thenurse–patient partnership. The MS APN can fulfill the identi-fied tasks/qualities of the scholarly inquiry domain by doingthe following.

• Providing authoritative information on all aspects of carefor patients with MS

• Exercising critical thinking in reviewing research-studydesigns, methodologies, and findings

• Incorporating theory into practice

• Educating professionals and nonprofessionals about MSthrough public speaking and written work, and by servingas a preceptor, mentor, and role model

• Regularly evaluating competencies, modifying as necessary,with regard to their applicability to patient care

• Providing leadership by adding to MS nursing knowledge

• Shaping public policy on MS healthcare

• Analyzing data pertaining to MS, MS nursing knowledge,and MS nursing performance

• Participating in patient-centered research studies,evidence-based research, and outcomes research

• Disseminating research findings

• Keeping current with evidence-based practices

• Evaluating quality assurance measures

• Showing intellectual curiosity and eagerness to expand anddevelop nursing knowledge

• Increasing professional involvement in lecturing, writing,and serving on advisory councils and editorial boards

• Coaching colleagues and other medical professionals intheir scholarly inquiries

Notes


20

The APN in Treatment Decisions and Symptom Management

An ever-growing armamentarium of MS agents and theirassociated treatment protocols has important implications

for advanced practice nursing in MS, starting with the APN’srole in therapeutic decision-making. The need to providepatients with relevant, up-to-date information and guidanceon new therapies (such as oral DMTs) or advances in existingtherapies (such as novel IFN formulations or enhanced deliv-ery systems using thinner needles) speaks directly to theAPN’s roles as educator, counselor, and consultant. In the ageof the Internet, the APN can act as expert, collaborator, andadvocate to help patients interpret the vast flow of healthinformation (and misinformation) and thereby participatemeaningfully in their own treatment decision-making process.

The use of DMTs requires that nurses master a complexskill set that includes both medical knowledge and interper-sonal skills.The MS APN should be familiar with the short-term and long-term efficacy data regarding DMTs andparticipate in the drug selection process. This calls for anunderstanding of the various agents’ mechanisms of action,diverse effects on the neurological system, and relativeadvantages and disadvantages (to the extent that they havebeen established by clinical trials). The MS APN should beable to explain side effects and demonstrate the facility tohelp patients manage them. As the primary source of infor-mation for the patient and family members, the MS APN isin the best position to involve them in the care continuumand reinforce their understanding of their specific regimenand the importance of adherence to it.

Because adherence to DMTs is vital in promoting their clinical effectiveness, it is extremely helpful to identify predic-tors of adherence and implement effective interventions. Inone study—in which 66% of patients with RRMS treated withglatiramer acetate were adherent and 43% were not—therewere 4 significant predictors of adherence: (1) self-efficacy, (2) hope, (3) perceived support of the physician, and (4) noprevious use of other immunomodulators.94 Level of disabilityand sociodemographic factors such as duration of MS, timeon glatiramer acetate treatment, age, gender, race, education,and income were not significant predictors.The study investi-gators concluded that providing greater support for patientswho have previously taken immunomodulators, enhancingself-efficacy, and inspiring hope are important in promotingadherence to therapy. All of these interventions are consistentwith the advanced practice nursing domain of comprehensivecare across the health–illness continuum discussed earlier.

A central focus of the MS APN practice is the evaluationand management of neurologic symptoms directly associ-ated with MS exacerbations and progression. Symptomatictreatments for MS include those used to control or alleviatespecific symptoms such as fatigue, bladder and bowel prob-lems, spasticity, depression, and pain. Other MS-relatedsymptoms may include tremor, sexual dysfunction, vertigo, orweakness. Effective management of MS symptoms througheducation, counseling, and rehabilitation—and, when indi-cated, pharmacotherapy—can significantly enhance patients’functioning and quality of life. Table 5 gives a brief synopsis ofsome of the most common symptoms associated with MSand the treatment options available.

Complex protocols for symptom assessment and management also require high skill levels. Bladder manage-ment interventions, for example, may include education on diagnostic procedures and strategies to improve themanagement of urinary dysfunction. MS APNs provide bladder training and positive reinforcement, instruction inself-catheterization or explanation of an indwelling catheter,and information on possible surgical options.95, 96 Bowelelimination and continence interventions include establish-ment of goals, instruction on managing dysfunction, adviceon nonpharmacologic interventions, nutritional guidance,bowel training, and treatment of constipation and impaction (Table 5).96-98

Symptom management begins with evaluating thecausative factors, which may be produced or worsened byMS or may arise from concurrent illness, medication, orother conditions. Medication for symptom relief (includingover-the-counter agents and alternative therapies) must beassessed for any contraindications suggested by MS itself orby DMT or other concomitant medication use. Patientsmust be counseled on realistic expectations for symptomtreatment and possible side effects, and supported in follow-up care.72

One further component of the therapeutic decision-making process is ideally suited to the roles and competen-cies of the APN: the inclusion of holistic wellness strategiesin the overall program of MS management. Given the long-term natural history of MS and its potential impact on physi-cal and psychosocial functioning, the importance of optimaladherence to fundamental health-promoting behaviors suchas diet, exercise, smoking cessation, and social and spiritualconnectedness cannot be overstated. MS APNs must stress


21

TABLE 5. Managing MS Symptoms

Symptoms Management Nursing issues

Fatigue

Bladder dysfunction

Bowel dysfunction

Depression

Pain

Spasticity

• Conditioning programs of graded exercise• Optimal nutrition• CNS stimulants (modafinil, pemoline)• Amantadine• SSRIs (eg, fluoxetine)

• Bladder training program • Anticholinergics (eg, oxybutynin)• Antimuscarinics (eg, tolterodine)• α-blockers (eg, terazosin)• Catheterization

Constipation:• Prevention strategies (fiber, fluids, exercise)• Education and support for bowel program• Stool softeners• Bulk-forming agents• Stimulants (occasional use only)• Lubiprostone

Urgency/diarrhea:• Bulk-forming agents• Anticholinergics• Antimuscarinics

• Cognitive-behavioral therapy or otherpsychotherapeutic options

• SSRIs and SNRIs (eg, fluoxetine, sertraline,paroxetine, citalopram)

• Tricyclic antidepressants (eg, amitriptyline,nortriptyline)

• Atypical antidepressants (eg, venlafaxine,bupropion)

• Supportive measures• Anticonvulsants (phenytoin, carbamazepine,

gabapentin, lamotrigine, pregabalin)• Tricyclic antidepressants• Duloxetine hydrochloride

• GABA antagonists (oral/intrathecal baclofen)• α-agonists (tizanidine)• Anticonvulsants (diazepam, clonazepam,

gabapentin)• Botulinum toxin• Surgical intervention

• Counsel on risk of restlessness/sleepdisturbance

• Supervise dosing schedule and titration

• Rule out UTI• Monitor retention and fluid balance• Consider role of other medications• Manage side effects (eg, dry mouth)

• Provide bowel training regimens• Consider effects of other medications

(eg, steroids, antibiotics)• Counsel on diet, exercise, lifestyle issues

• Evaluate type and degree of depression;assess suicide risk

• Consider contribution of other medications(eg, interferons)

• Assess family and social support network• Facilitate use of psychiatric care• Counsel on medications (eg, delayed efficacy

and side effects of antidepressants)• Re-assess at follow-up

• Watch for sedation• Start with low doses, titrate up• Monitor outcomes and alter treatment as

necessary

• Time doses to maintain therapeutic levels• Titrate doses up• Watch for sedation or cognitive symptoms • Consider combination therapy


22

wellness-focused lifestyles. Weight control and regular exer-cise are important to cardiac health, bone health, flexibility,and muscle strength—all important to maximize mobility.Smoking has been found to be a risk factor in the develop-ment of MS as well as a factor linked to a more progressiveMS disease course.99-102

Despite advances in pharmacologic therapy, many patients will contend with symptoms, relapses, and progres-sive disability that will negatively affect their quality of life.

The MS APN should be able to refer patients affected bymental and physical disabilities brought on by MS to alliedhealth professionals, such as occupational therapists, speechpathologists, physical therapists, social workers, and psychol-ogists. The proactive involvement of the MS APN can raisepatients’ and their care partners’ awareness of, and access to,complementary non-drug modalities and resources, such assupport groups, that may ameliorate some of the burden ofdisease.

Notes


23

P rimary care of patients with MS is the promotion of general health and wellness across their life span.

Whereas the primary care provider (PCP) may see thepatient only once a year or for acute episodic care, the MS APN typically sees the patient 3 or more times a year. Because of this, the MS APN is in a unique position to identify primary care issues and make appropriate referrals.

Although many primary care problems are directly relatedto MS, others are not. However, all health concerns have animpact on MS and may contribute to symptoms and relapses.The important thing is to identify the issue and either treat it(if appropriate or feasible) or refer the patient to primarycare services. For the MS APN, primary care encompassesthe following.103

• Identifying and addressing the patient’s primary care needsalong a continuum of health as part of holistic care

• Recognizing and assessing (but not necessarily treating)the patient’s symptoms and non-MS-related conditions

• Referring the patient to appropriate providers

• Assessing outcomes, including adherence to recommenda-tions, during subsequent visits

• Educating both patients and other healthcare providersabout primary care needs within the context of MS

The MS APN and the PCP should both be alert for deficits that often occur with MS, factors that contribute to these deficits and/or exacerbate MS, and physical andmental conditions and changes directly related to MS(Table 6). Assessment of the patient’s health beliefs regard-ing MS is important, as these beliefs often influence willingness to accept advice, participate in care, and adhere to therapy.

Optimal delivery of primary care requires that patients

be fully involved in the care process, but this is not alwaysthe case. Social psychologists and health researchers havedeveloped several models to describe why patients may ormay not choose to become fully engaged in the process. Forexample, the Health Belief Model indicates that patients aremore likely to participate if they are aware that (1) they aresusceptible to a potentially serious health problem, (2) takingaction may decrease their susceptibility, and (3) the likelybenefits of acting outweigh the costs.104-106 This model andothers serve as useful guides to the MS APN in establishingthe care relationship, providing effective education and sup-port, and coordinating diverse aspects of care with appro-priate specialists.

In addition to determining the patient’s health beliefs, theMS APN should assess the patient’s personal characteristicsand situations, barriers to care, existing support systems, andimplications for polypharmacy and complementary thera-pies. Having MS increases the possibility of known disease-related risk factors that can alter the course of MS, andpatients with MS must understand that they face the samehealth risks as patients without MS, with routine healthscreenings a continued necessity.

MS-specific needs to consider when promoting wellnessin patients with MS are listed in Table 7.107-120 Certain special needs apply to all patients, whereas others applyspecifically to women, men, or those with advanced disease.

Time management and productivity are additional challenges that can limit the amount of nursing care that MS APNs provide for patients. In addition, limitations due to arbitrary regional and geographic differences may exist in many practice settings. Another significant issue for the MS APN is the cost of chronic care, medications, and hospi-tal admissions for long-term sequelae and comorbidities, allof which tend to increase with the level of the patient’s dis-ability. The economic realities of treating a chronic illness areever-present concerns.

Primary-Care Needs in Multiple Sclerosis


24

TABLE 6. Primary Care Problems in Patients With MS

KEY CHALLENGES (MS directly*, general health issues†)Pressure ulcers* Hypertension† Dental problems†

Osteoporosis† Pneumonia† Hearing changes/loss†

Thyroid disease† Sexual dissatisfaction† Preventive immunizations†

Diabetes† Mental health problems† Disease-related immunizations†

Cancer† Vision problems† Urinary tract infections*Deep vein thrombosis†

MS-RELATED RISK FACTORS

Biological Factors (that contribute to the key challenges)Genetic predisposition Comorbid conditions PolypharmacyHigh-risk medications (antiepileptics, chemotherapy, steroids, interferon beta, antidepressants)

Lifestyle and Behavioral Factors (that contribute to the key challenges)Inadequate diet Nicotine use Sedentary lifestylePoor hydration Alcohol abuse Inadequate personal hygieneObesity

Physical Conditions (caused by MS)Muscle weakness Spasticity Incontinence (bowel and bladder) FatigueMyalgia Paresthesia/sensory loss Vertigo Sleep disturbancesTremor Pain SeizuresDependent edema (related to autonomic nervous system changes, obesity, sedentary lifestyle)Impaired mobility (gait disturbance, ataxia, paraplegia, quadriplegia)

Mental Changes (caused by MS)Depression AnxietyCognitive changes (short-term memory loss, impaired executive function and/or judgment)

Social/Environmental Factors (resulting from MS or contributing to stress-related MS relapses)Isolation Inadequate support system Financial restraintsLack of transportation Inaccessible facilities Environmental pollutantsBiased attitudes of providers Lack of adaptable medical equipment

RECOMMENDED SCREENING TESTSMammogram/clinical breast exam for breast cancerPap smear for cervical cancerPSA/clinical testicular and rectal exam for prostate and testicular cancerHemoccult/colonoscopy for colon and rectal cancerVisual inspection of the skin for signs of pressure ulcers, melanomaBone densitometry (DEXA) for osteoporosisChest x-rayCardiogramComprehensive metabolic profile (random glucose, liver enzymes, random cholesterol) annuallyCBC with differential annuallyThyroid function testing annually


25

TABLE 7. Special Primary Care Needs of Patients with MS107-121

All Patients With MS• Osteoporosis prevention and treatment strategies• Coping skills for certain issues

– Sexual dissatisfaction– Incontinence

• Effects of exercise on reducing risk of– Cardiovascular disease– Osteoporosis

• Vaccinations/immunizations– Hepatitis A– Hepatitis B – Influenza– Tetanus– Other infectious diseases

• Strategies to improve quality of life– Improve diet and nutrition – Stress management– T’ai chi– Yoga

• Physical therapy for general mobility and functionalindependence

Patients With Advanced MS• Prevention and treatment of pressure ulcers• Prevention and treatment of respiratory complications• Occupational and speech therapies to aid in adaptation to

physical and mental limitations

Women With MS• Reproductive issues

– Contraception– Pregnancy

• Access to facilities for women with disabilities– Pap smears– Mammograms

• Thyroid disorders

Men With MS• Routine screening for prostate cancer• Concerns about erectile dysfunction

Notes

In today’s changing healthcare environment, it has become increasingly important to employ evidence-based

approaches to practice, and to identify and measure the out-comes of various healthcare interventions. Whereas olderparadigms of clinical practice were based on clinical experi-ence, training and education, and expertise, the newer para-digm maintains that rules of scientific evidence are neededto guide clinical practice correctly.121 For the APN, protocolsdeveloped to shape practice to achieve successful outcomesprovide a unique opportunity to promote an evidence-based practice model, particularly in the area of patientassessment. However, despite the emphasis on evidence inadvanced practice nursing, there is a gap in outcomesresearch that specifically targets the effects of interventionsby APNs and the care they provide for patients.122

As Oermann and Floyd point out, early outcomes studiesin nursing focused on costs and length of stay but neglectedto consider outcomes of APN practice such as symptomresolution, functional status, quality of life, adherence to therapy, knowledge of patients and families, and patient andfamily satisfaction.122 These outcomes are considered asimportant as cost in a comprehensive model that includes 4 types of outcomes: clinical, functional, costs, and satisfac-tion. Adherence is particularly important because it is essen-tial for the effectiveness of therapy and overall outcome andis an area in which APNs can have direct influence.

There is evidence demonstrating positive APN outcomes with some populations, such as caregivers of the elderly, those experiencing heart failure and stroke, andwomen pregnant with twins.123-127 To date, there is still littleevidence of outcomes of the practice of the MS APN. Con-tributing to the gap is the difficulty of measuring nurse-sensi-tive outcomes in chronic progressive diseases, like MS, thatare not characterized by a sudden, distinct event with severeconsequences. Rather, they involve a continuous diminutionof physical and/or mental abilities, affecting several functionsand producing a number of different symptoms over a longperiod of time.128

In a review of the literature reported in 2001,129 De Broe,Christopher, and Waugh found only 1 study evaluating thebenefits of MS APNs (Kirker, Young, and Warlow, 1995)130

and 2 research studies involving MS APN nursing outcomes:1 funded by the South Bank University in London and theMS (Research) Charitable Trust,131 the other funded by theMS Society of Great Britain and Northern Ireland. In the

study by Kirker et al, patients found MS APNs to be helpful inimproving their knowledge, ability to cope, mood, and confi-dence about the future, whereas general practitioners foundthem to be helpful with their MS patients.130 In the SouthBank University and MS Charitable Trust study, new insightswere gained into MS specialist nurses’ role in emotionally andpractically supporting people with MS.131 Employment ofAPNs also lead to significant cost and resource savings, asreported to the National Health Survey (NHS).131

Nurses at all levels of practice spend substantial amountsof time with patients, usually more time than any otherhealth provider. Intuitively, nurses know that the areas inwhich they provide care—support, comfort, mobility,hygiene, symptom management, health promotion—are cru-cial to positive health outcomes. MS APNs also provide carein areas that affect the patient’s quality of life, such as pain,suffering, grief, anxiety, and social handicaps. Researchdemonstrating the outcomes of this care not only is sparsebut in many cases would be better measured by quality-of-life instruments than in dollars.128,132 There is a need to document the value of APNs and the benefits of their inter-ventions with regard to multifaceted outcomes, such asimproved health, reduced costs, improved patient satisfac-tion, and increased efficiency.133

Measuring the clinical and economic impact of MS APNinterventions is further limited when different studies usedifferent criteria to assess treatment outcomes. For exam-ple, treatment outcomes may be assessed on the numberand severity of relapses, the number of active lesions on anMRI scan, changes in the Expanded Disability Status Scale(EDSS) score, or other criteria.128

Byers and Brunell have pointed out that quality of careand its outcomes are valued differently by patients and fami-lies, MS APNs, physicians, managed care organizations, health-care systems, payers, regulatory agencies, and society.134 Forexample, patients may place a high value on education pro-vided by the MS APN because it improves their ability tocope with MS, whereas payers may value it less highly unlessit reduces costs.

MS APN OUTCOME MEASURES

Outcome measures used to assess the effectiveness ofadvanced practice nursing are care-related, patient-related,and performance-related. However, because no single set of


26

Measuring Outcomes


27

outcomes is appropriate for all APN outcome evaluations,selected outcomes should be easily identifiable and measura-ble and directed toward meeting the goals of the outcomeassessment. Regardless of the outcome measures chosen,the goal should be to ob tain valid and reliable results.135

In a consensus-based study, 8 outcomes have been identifiedfor the APN to attain the primary goal of optimal health andwellness for those living with MS (Figure 5). Three commonelements—learning, coping, and self-efficacy—have beenidentified as being integral to the attainment of the eightoutcomes. For each outcome, factors specific to MS APNsand relevant outcome measures are addressed in greaterdetail in Table 8.136-141

Learning

Coping

Self-Efficacy

OptimalHealth and

Wellness

Cost

Symptom Resolution &Reduction

Satisfaction

Patient & FamilyKnowledge

Prevention ofComplications

Adherence

Well-being

Continuity of Care

FIGURE 5. Advanced Practice Nursing Outcomes inMS

Notes

TABLE 8. Measuring Outcomes in MS98-103

OUTCOMES MS APN–SPECIFIC FACTORS MS APN INTERVENTIONS

ADHERENCE • Treatment and rehabilitation The MS APN can improve adherence to the therapeutic • Follow-up regimen by providing support, encouragement, information

about side effects and adherence, and follow-up.

COST • Length of office visit MS APNs can influence costs by controlling where and to• Days in the hospital whom a patient is referred, by preventing certain costly• Use of equipment MS-related complications, and by lobbying for • Medications reimbursement of MS APN interventions. • Use of resources• Home healthcare• Incidentals• Lost workdays• Post-hospitalization costs

SYMPTOM RESOLUTION This specifically includes resolution or MS APNs promote symptom resolution and reduction by AND REDUCTION reduction of spasticity, fatigue, bladder interventions such as appropriate diagnosis of symptoms,

symptoms, and pain, and improvement in assessment of contributing factors, prescription of mood and mobility. appropriate treatments, and focusing on functional

outcomes. Other interventions include educating the patient about symptom management, modifying the treatment plan as necessary, including the family in the patient’s care, implementing preventive measures andinstructing the patient and family in symptom prevention and reduction, and referring the patient to an appropriate specialist when necessary.

PREVENTION AND REDUCTION • Injection-site reactions MS APNs can prevent or reduce complications byOF COMPLICATIONS • Urinary tract infections identifying the risk factors for these complications,

• Altered or impaired skin integrity that can educating patients and families to recognize the first signsincrease the risk for pressure ulcers and institute preventive measures, and implementing

• Pneumonia appropriate compensatory strategies.

WELL-BEING • Positive health perceptions MS APNs influence well-being by utilizing a holistic • Improved satisfaction with life approach to care, including the family in the patient’s care,• Improved mood and focusing on aspects of health and wellness in• Stress reduction addition to coping with disease.• Improved ability to cope• Enhanced self-efficacy• Sense of hope

PATIENT AND FAMILY • Access to care and available services MS APNs influence patient and family satisfaction with care SATISFACTION WITH CARE • Comprehensiveness of care by fostering communication, encouraging patients and

• Care delivery families to express satisfaction or dissatisfaction with care, • Perception of being well cared for98 reviewing and revising treatment goals and their attainment,

and clarifying needs and expectations as necessary.

CONTINUITY OF CARE AND Factors include utilization of related disciplines, MS APNs affect continuity of care and care management CARE MANAGEMENT reduced number of visits to the emergency room by making follow-up visits and phone calls, including the

and office or clinic, and reduced number of family in the patient’s care, making referrals as necessary admissions for long-term care. and following up, and using clinical pathways that include

multiple providers as a guide through the entire course of treatment.

PATIENT AND • MS MS APNs educate the patient and family about MS, FAMILY KNOWLEDGE • The MS disease process providing appropriate educational materials, encouraging

• Medications patients and families to ask for any additional information • MS-related symptoms they feel they need, and ascertaining whether the education• The plan of care and/or educational materials provided were adequately • The role of the multidisciplinary team involved understood.

in MS care• What to expect during the disease course• Supports and resources


28

OUTCOME MEASURES

• Chart review• Patient and family reports• Drug renewal sheets• Consultation sheets for rehabilitation services and physical and occupational therapy• Follow-up on appointments kept

Direct costs• Departmental tracking• Chart reviews of interventions • Utilization of resources

Indirect costs• Lost wages of the patient • Lost wages of family members who take time off to provide care

• Documented patient reports• Visual analog scale, which measures pain intensity on a 0-to-10 scale• Fatigue Impact Scale, which measures the impact of MS fatigue on various aspects of the patient’s life • SF-36, a multidimensional instrument that is part of the Medical Outcomes Survey; it measures 36 items in 8 subscales:

– Physical functioning– Role limitations due to physical problems– Social functioning– Bodily pain– General mental health– Role limitations due to emotional problems– Vitality– General health perceptions

• MS Quality of Life scale, a multidimensional, patient-reported, MS-specific instrument that includes the SF-36 plus 4 items on health distress, 4 on sexual function, 1 on satisfaction with sexual function, 2 on overall quality of life, 4 on cognitive function, and 1 each for energy, pain, and social function

• Chart review• Patient reports• Hospital admission/emergency room visit rates

• Jalowiec Coping Scale, which reflects the ability to cope, the degree of self-reliance or reliance on others, and the coping strategies employed99

• Mishel Uncertainty Scale, also known as the Mishel Uncertainty in Illness Scale (MUIS), a self-administered questionnaire that assesses the inability to determine the meaning of illness-related events100

• Beck Depression Scale, also known as the Beck Depression Inventory, a 21-item self-report used in many illness states to measurethe severity of depression101

• Herth Hope Index, a 12-point abbreviated version of the Herth Hope Scale, assesses a patient’s overall hope level102

• Multiple Sclerosis Self-Efficacy Scale, an 18-item instrument specifically designed for individuals with MS that asks them to rate on a scale of 10 (very uncertain) to 100 (very certain) how certain they are that they will be able to perform specific behaviors103

• Questionnaire designed to address areas of satisfaction/dissatisfaction with care

• Hospital admission/emergency room visit rates• Self-reports of support systems and resources• Referrals

• Pretests and posttests• Determinations of perceived knowledge• Assessment of how well self-care skills are being performed• Review of logs documenting patient and family calls and reasons for the calls


29


30

Conclusion

TThis monograph is the third in a series devoted to the examination of advances in

treatment options that have dramatically altered the roles of nurses providing care for

patients with MS. The availability of DMTs, in conjunction with the refinements in diagnostic and

monitoring technologies and the advent of complex treatment protocols, mandates a pivotal

place for nurses in the development and provision of comprehensive care strategies. With this

third edition, all 3 monographs in the series have been revised to provide current clinical data

and current perspectives on MS nursing practice.

Key Issues in Nursing Management explores strategies to assess and overcome the

cognitive changes experienced by patients over their lifetimes, thus empowering patients to

optimize their quality of life. Its third edition revisited these key issues, with a sharper focus on

adherence to long-term treatment regimens and the nursing skills requisite to establish and

nurture relationships with patients. Best Practices in Nursing Care addresses the evolving role of

nurses in this field, describing a philosophy and framework, domains and competencies, and

best practices in MS nursing. Its third edition provides valuable new information to enhance

MS nursing care, particularly with regard to disease management, pharmacologic treatment,

and nursing research.

The present updated monograph defines the roles and responsibilities of the MS APN and

the APN’s domains of practice. It examines the tools used to validate the effectiveness of this

model of care and describes the evolution of advanced practice nursing, specifically MS advanced

practice nursing. This monograph also provides recent evidence substantiating the effectiveness

of DMTs and lauds and emphasizes the value of a multidisciplinary approach to the complex

spectrum of MS care.


31

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Acknowledgement

WORKSHOP GROUP 1: Roles

Chairs:Kathleen M. Costello, MS, ANP-BC, MSCNColleen J. Harris, MN, NP, MSCN

Participants:Mary Baird, ARNP, MSCNBarbara Bishop, ANP, MSCNTrudy Campbell, RN, MS, MSCNS

Kim Havins, RN, MSN, CCRN, FNP-BCMartha Lightfoot, MSN, RNP, MSCNSandra McGrath, NP, MSCN

Amy Perrin-Ross, RN, MSN, CNRN, MSCNJennifer Stratton, NPKathy Wall, RNP, NP

WORKSHOP GROUP 2: Domains

Chair:Heidi W. Maloni, PhD, ANP-BC, CNRN, CRNP,MSCN

Participants:Tally N. Bell, RN, ARNPCheryl Blaschuk, RN, MSN, FNPJulie Carpenter, RN, MS, FNPMary Kay Fink, RN, MSN, CNRN, MSCN, APN

Heli Hunter, NP, MSCNPat Loge, MSN, CNM, FNPCLinda A. Morgante, RN, MSN, CRRNGermina Rio, MN, ARNP, CS

Elizabeth Sweat, RN, MSN, CRNPSharon Zboray, NP

WORKSHOP GROUP 3:Primary Care Needs

Chairs:Eileen Gallagher, RN, NP, MSNJune Halper, MSN, APN-C, FAAN, MSCN

Participants:Jeanne Benson, CFNPSherry Cadenhead, RN, MSLinda Crossett, MSN, APRN, BCJoanne Major, RN, CNS

Marie Namey, RN, MSN, MSCNB. Floella Shupe, MN, ACNPRuth Taggart, RN, NP

WORKSHOP GROUP 4:Measuring Outcomes

Chair:Diane Lowden, N MSc (A), MSCN

Participants:Aliza Ben-Zacharia, ANP-C, MSCNMichele Callahan, NPTim Dillon, FNP

Cira Fraser, PhD, RN, ACNS-BCJulia Klein, RN, MSN, MS, MSCNLynn McEwan, MScN, MSCN

Carrie Sammarco, DNP, ANP-C, MSCNTeri Tupper, ARNP

*Participant names and credentials may have changed. Updated information provided where available.

The editors of this edition of Advanced Practice Nursing in Multiple Sclerosis: Advanced Skills, Advancing Responsibilities acknowledge the hard work and expertise provided by theparticipants* of the Advanced Practice Nurse Advisory Consensus Meeting held at Niagara-on-the-Lake, Ontario, Canada, in 2002. Without their contributions both at the meeting andwithin their daily practices of providing care to patients with MS, the current and previous editions of this monograph would not be possible.

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